OXYBUTYNIN HYDROCHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYBUTYNIN HYDROCHLORIDE

Available from:

SYRI Limited, t/a Thame Laboratories

ATC code:

G04BD04

INN (International Name):

OXYBUTYNIN HYDROCHLORIDE

Dosage:

5 MG/5ml

Pharmaceutical form:

Oral Solution

Administration route:

Oral use

Units in package:

Pack size: 100ml and 150ml

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Syri Limited

Therapeutic group:

anticholinergic as well as antispasmodic

Therapeutic area:

oxybutynin

Therapeutic indications:

Urinary incontinence, urgency and frequency in the unstable bladder, whether due to neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida, or to idiopathic detrusor instability (motor urge incontinence).

Authorization status:

Not Marketed

Authorization date:

2015-03-27

Patient Information leaflet

VAR/IB-006
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYBUTYNIN HYDROCHLORIDE 5MG/5ML ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
►
Keep this leaflet. You may need to read it again.
►
If you have any further questions, ask your doctor or pharmacist.
►
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
►
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
IN THIS LEAFLET:
The name of your medicine is Oxybutynin hydrochloride 5mg/5ml Oral
Solution but it will be referred
to as Oxybutynin throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Oxybutynin is and what it is used for
2. What you need to know before you take Oxybutynin
3. How to take Oxybutynin
4. Possible side effects
5. How to store Oxybutynin
6. Contents of the pack and other information
1. WHAT OXYBUTYNIN IS AND WHAT IT IS USED FOR
Oxybutynin contains a medicine called oxybutynin hydrochloride. This
belongs to two groups of
medicines called ‘anticholinergics’ and ‘antispasmodics’.
It works by relaxing the muscles of the bladder and stops sudden
muscle contractions (spasms). This
helps control the release of water (urine).
OXYBUTYNIN CAN BE USED IN ADULTS AND CHILDREN 5 YEARS OR OLDER TO
TREAT:
► loss of control in passing water (urinary incontinence)
► increased need or urgency to pass water (urine)
► night time bedwetting, when other treatments have not worked
You must talk to a doctor if you do not feel better or if you feel
worse
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYBUTYNIN DO NOT TAKE OXYBUTYNIN IF:
► you are allergic (hypersensitive) to oxybutynin hydrochloride or
any of the other ingredients (see
section 6
‘
Contents of the pack and other information’).
Signs of an allergic reaction include: a rash, swallowing or breathing
pr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxybutynin Hydrochloride 5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml solution contains 5mg oxybutynin hydrochloride.
_Excipients with known effect:_ Each 5ml of solution contains 1.3gm
liquid sorbitol (non-crystallising) (E420) and 6.0mg
methyl parahydroxybenzoate (E218).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, colourless solution with raspberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Urinary incontinence, urgency and frequency in the unstable bladder,
whether due to neurogenic bladder disorders
(detrusor hyperreflexia) in conditions such as multiple sclerosis and
spina bifida, or to idiopathic detrusor instability
(motor urge incontinence).
PAEDIATRIC POPULATION
Oxybutynin hydrochloride is indicated in children over 5 years of age
for:
Urinary incontinence, urgency and frequency in unstable bladder
conditions due to idiopathic overactive
bladder or neurogenic bladder disorders (detrusor overactivity).
Nocturnal enuresis associated with detrusor overactivity, in
conjunction with non
-
drug therapy, when other
treatment has failed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
The usual dose is 5mg (5ml) two or three times a day. This may be
increased to a maximum of 5mg (5ml) four times a
day to obtain a clinical response provided that the side effects are
tolerated.
ELDERLY (INCLUDING FRAIL ELDERLY):
The elimination half-life is increased in the elderly. Therefore, a
dose of 2.5mg (2.5ml) twice a day, particularly if the
patient is frail, is likely to be adequate. This dose may be titrated
upwards to 5mg (5ml) twice a day to obtain a clinical
response provided that the side effects are tolerated.
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